Solid Tumor Clinical Trial
Official title:
Multi-center, Non-interventional, Prospective Registry Study on the Treatment of Solid Tumors With Mismatch Repair Deficiency or Microsatellite Instability
NCT number | NCT06004713 |
Other study ID # | LGH2023093 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 7, 2023 |
Est. completion date | February 2026 |
This study is a multi-center, non-interventional, prospective clinical observational study, aiming to evaluate the effectiveness and safety of subsequent treatment in dMMR/MSI solid tumor patients who have never received ICIs under real-world conditions. Particular attention is paid to the efficacy in populations where treatment plans are adjusted based on ctDNA, and potential predictive or prognostic biomarkers are explored.
Status | Recruiting |
Enrollment | 190 |
Est. completion date | February 2026 |
Est. primary completion date | February 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Sign the informed consent form and voluntarily participate in this study; - Age = 18 years old; age should also be =75 years old in Cohorts B, C, D; - Histologically or cytologically confirmed to have a solid malignant tumor and confirmed by immunohistochemistry to be dMMR or confirmed by PCR/NGS to be MSI; - The researcher determines that the patient can receive anti-tumor treatment; - Have evaluable lesions Exclusion Criteria: - Other malignant tumors within 5 years before joining the study, except for cured skin squamous cell carcinoma, basal cell carcinoma, non-muscle invasive bladder cancer, localized low-risk prostate cancer (defined as stage =T2a, Gleason score =6 points, and prostate cancer diagnosed with PSA =10 ng/mL (if measured). Patients who have received radical treatment and have no prostate specific antigen (PSA) biochemical recurrence can participate in this study), cervical/breast carcinoma in situ, and Lynch syndrome; - Evidence already exists that the patient is a pregnant or lactating woman; - Previous treatment with immune checkpoint inhibitors or T cell co-stimulatory drugs, including but not limited to PD1, CTLA4, LAG3, and other immune checkpoint blockers, therapeutic vaccines, etc.; patients exposed to ICIs in perioperative setting are allowed to be enrolled if disease relapse after more than 6 months since the last dose of ICIs; - Other situations deemed by the researcher to be unsuitable for inclusion in the study |
Country | Name | City | State |
---|---|---|---|
China | Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute | Beijin | Beijing |
China | Department of Medical Oncology, Peking University First Hospital | Beijing | |
China | Department of Oncology, Beijing Luhe Hospital Affiliated to Capital Medical University | Beijing | |
China | Department of Oncology, Peking University Shougang Hospital | Beijing | |
China | Department of Oncology, The Affiliated Hospital of Qingdao University | Qingdao | Shandong |
China | Medical Oncology Department of Gastrointestinal Cancer, Liaoning Cancer Hospital & Institute | Shengyang | Liaoning |
China | Department of Gastroenterology and Hepatology, The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei |
China | Department of Gastroenterology, Shanxi Province Cancer Hospital/Shanxi Hospital Affiliated to Cancer Hospital | Taiyuan | Shanxi |
China | Department of Gastrointestinal Oncology, Tianjin Medical University Cancer Institute and Hospital | Tianjin | |
China | Department of Oncology, The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Peking University Cancer Hospital & Institute |
China,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival (PFS) determined by the researchers according to the RECIST 1.1 criteria.. | Progression-free survival (PFS) is defined as the time from the date of the first dose to the earlier of the dates of the first objective documentation of radiographic progressive disease (PD) or death due to any cause. | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose | |
Secondary | Overall survival | Overall survival (OS) is defined as the time from the date of first dose to the date of death from any cause. | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose | |
Secondary | Overall response rate | Objective response rate (defined as CR+PR) will be reported based on investigator's evaluation. | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose | |
Secondary | Disease control rate | Disease control rate (defined as CR+PR+SD) will be reported based on investigator's evaluation. | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose | |
Secondary | Duration of response | Duration of response (DOR) is defined as the time from the date of the first response to the first objective documentation of radiographic progressive disease (PD) or death due to any cause. | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose | |
Secondary | Treatment-related adverse event | A treatment-related adverse event (TRAE) is defined as any adverse event not present prior to the initiation of drug treatment or any adverse event already present that worsens in intensity or frequency following exposure to the drug treatment. TRAEs were graded using National Cancer Institute (NCI)-CTCAE version 5.0. | Informed consent to 30 days after last dose of treatment |
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